B P1 C12 Wearable Devices in Cardiovascular Medicine Flashcards
_____ wearables comprise almost half of the United States and international segments of the wearables market
Wrist-worn
Wearable devices are part of a larger concept in medicine called, “_____,” which is a broad term that describes the application of digital information or data and communications technologies to improve patient health, population health, and care delivery.
Digital health
Digital health is a multidisciplinary domain that includes elements of mobile health, health information technology, wireless or connected health, big data, wearable technologies, telemedicine and remote care, precision and personalized medicine, genetics, and artificial intelligence.
Most wrist-worn wearable devices have heart rate tracking. ____ is an inexpensive optical measurement technique that can estimate relative changes in blood flow.A light source is aimed at the skin, typically underneath the face of the head of the fitness band or watch. An adjacent photodetector measures the reflected light, which can estimate relative changes in blood volume.
Photopletysmography (PPG)
With continuous sampling, PPG can capture the cardiac cycle and estimate the pulse rate.
The _____ algorithm was tested at scale in a single-arm, unblinded, investigational device exemption study.6 Inclusion criteria included age ≥22, possession of compatible Apple watches and phones, no prior history of AF,and U.S.residency.
Over an 8-month period between 2017 and 2018, the study enrolled 419,297 U.S. participants. Overall 0.52% of participants received an irregular rhythm notification.
Among 450 participants with notifications who received ambulatory ECG patch monitoring, AF was a detected on that patch in 34% (97.5% CI 29% to 39%).
The positive predictive value for an irregular rhythm notification was 0.84 (95% CI 0.76 to 0.92).
Because only notified participants received “gold standard” ECG monitoring, the study was unable to assess sensitivity or specificity.
Apple algorithm
Although these studies indicate the promise for undiagnosed AF detection in an at-risk population, the FDA views this class of algorithms as _____ tools, rather than serving as more definitive diagnostic tests
Prediagnostic
Confirmation by an ____ is essential; the irregular rhythm notification alone is insufficient for clinical diagnosis
ECG
Irregular rhythm notification alone does not suffice to make a clinical diagnosis of AF without ECG confirmation
The movement tracking features may be useful to provide a general sense of baseline level of activity and exercise. However, automated exercise logging, step counts, and sleep can be inaccurate, and these data are used best together with a _____
History and patient report of activity
The _____ study (NCT04276441) aims to randomize 150,000 persons age 65 years to a smartwatch with AF detection capabilities and a study app for digital health engagement. Outcomes include clinical diagnosis of AF, anticoagulation adherence, and incidence of a composite cardiovascular outcome.Other studies are in various stages of development.
HEARTLINE study
